Cipla Limited (BSE: 500087; NSE: CIPLA EQ; and hereafter referred to as "Cipla") today announced that it has received final approval for its Abbreviated New Drug Application (ANDA) for Esomeprazole for Oral Suspension 10mg, 20mg and 40mg from the United States Food and Drug Administration (US FDA). Cipla is the first company to file for the 10mg strength.
Cipla's Esomeprazole for Oral Suspension 10mg, 20mg and 40mg is AB-rated generic therapeutic equivalent version of AstraZeneca Pharmaceutical's Nexium®. It is a proton pump inhibitor indicated for the following:
- Treatment of gastroesophageal reflux disease (GERD).
- Risk reduction of NSAID-associated gastric ulcer.
- H. pylori eradication to reduce the risk of duodenal ulcer recurrence.
- Pathological hypersecretory conditions, including Zollinger-Ellison syndrome.
According to IQVIA (IMS Health), Nexium® and its generic equivalents had US sales of approximately $70M for the 12-month period ending November 2019. The product is available for shipping immediately.
Shares of CIPLA LTD. was last trading in BSE at Rs.376.7 as compared to the previous close of Rs. 377.65. The total number of shares traded during the day was 153574 in over 9414 trades.
The stock hit an intraday high of Rs. 394.7 and intraday low of 374.2. The net turnover during the day was Rs. 58745446.